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Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.
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This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.
NOTE: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine + Cognitive Training | Experimental |
| |
| Ketamine + Sham Training | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ketamine | Drug | Single subanesthetic infusion of ketamine (0.5mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +24 hours |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +5 days |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +12 days |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +1 month |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +3 months |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +6 months |
| Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +24 hours |
| Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review | Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide | infusion +6 months |
| Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS) |
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Inclusion Criteria:
Participants will:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine + Cognitive Training | Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training |
| FG001 | Ketamine + Sham Training | Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine + Cognitive Training | Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training |
| BG001 | Ketamine + Sham Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +24 hours |
|
24 hours
Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine + Cognitive Training | Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anxiety | Psychiatric disorders | Systematic Assessment |
Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Price | University of Pittsburgh | 412-383-2150 | pricerb@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2020 | Nov 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Cognitive training | Behavioral | 8 sessions of computer-based cognitive training |
|
| Sham Training | Behavioral | 8 sessions of computer-based sham training |
|
| infusion +5 days |
| Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +12 days |
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +1 month |
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +3 months |
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +6 months |
Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses. |
| infusion +6 months |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +24 hours |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +5 days |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +12 days |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +1 month |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +3 months |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +6 months |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +24 hours |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +5 days |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +12 days |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +1 month |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +3 months |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +6 months |
Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)
Sham Training: 8 sessions of computer-based sham training
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | Mean | Standard Deviation | units on a scale |
|
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | Measure not acquired at baseline from 1 participant | Mean | Standard Deviation | units on a scale |
|
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | Measure not acquired at baseline from 2 participants | Mean | Standard Deviation | units on a scale |
|
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | Measure not acquired at baseline from 4 participants | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +5 days |
|
|
|
| Primary | Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +12 days |
|
|
|
| Primary | Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +1 month |
|
|
|
| Primary | Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +3 months |
|
|
|
| Primary | Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +6 months |
|
|
|
| Primary | Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +24 hours |
|
|
|
| Primary | Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +5 days |
|
|
|
| Primary | Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +12 days |
|
|
|
| Primary | Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +1 month |
|
|
|
| Primary | Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +3 months |
|
|
|
| Primary | Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +6 months |
|
|
|
| Secondary | Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review | Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide | All participants who were assigned to the arm. | Posted | Count of Participants | Participants | infusion +6 months |
|
|
|
| Secondary | Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS) | Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses. | All participants who were assigned to the arm and were willing and able to complete at least one CSSRS interview at any point during follow-up. | Posted | Count of Participants | Participants | infusion +6 months |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +24 hours |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +5 days |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +12 days |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +1 month |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +3 months |
|
|
|
| Secondary | Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | All participants who were assigned to the arm and were willing and able to complete this specific measure. | Posted | Mean | Standard Deviation | score on a scale | infusion +6 months |
|
|
|
| Secondary | Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients. | Posted | Mean | Standard Deviation | score on a scale | infusion +24 hours |
|
|
|
| Secondary | Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients. | Posted | Mean | Standard Deviation | score on a scale | infusion +5 days |
|
|
|
| Secondary | Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients. | Posted | Mean | Standard Deviation | score on a scale | infusion +12 days |
|
|
|
| Secondary | Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients. | Posted | Mean | Standard Deviation | score on a scale | infusion +1 month |
|
|
|
| Secondary | Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients. | Posted | Mean | Standard Deviation | score on a scale | infusion +3 months |
|
|
|
| Secondary | Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients. | Posted | Mean | Standard Deviation | score on a scale | infusion +6 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Ketamine + Sham Training | Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training | 0 | 9 | 0 | 9 | 9 | 9 |
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| decreased energy | General disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| difficulty sleeping: too little | Psychiatric disorders | Systematic Assessment |
|
| difficulty sleeping: too much | Psychiatric disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| emotional indifference | Psychiatric disorders | Systematic Assessment |
|
| feeling 'high' | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| loss of sexual desire | Reproductive system and breast disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| restlessness | General disorders | Systematic Assessment |
|
| sweating | General disorders | Systematic Assessment |
|
| tremors | Nervous system disorders | Systematic Assessment |
|
| trouble achieving orgasm | Reproductive system and breast disorders | Systematic Assessment |
|
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|